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510(k) Data Aggregation
(194 days)
The t:slim X2 Insulin Pump with Interoperable Technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The Pump is intended for single patient, home use and requires a prescription.
The Pump is indicated for use in individuals 2 years of age and greater.
The Subject Device, t:slim X2 insulin pump with interoperable technology ("t:slim X2 insulin pump", "the pump") is an is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The front of the pump includes a color touch screen display that has a capacitive touch panel that detects a finger touch. The Screen On Button on the side of the insulin pump is surrounded by an LED indicator light. This button is used to turn on the touch screen display so that the user can operate their System. The Screen On Button also provides users with a quick bolus option, which is a feature that allows a user to program and deliver a bolus of insulin through a sequence of presses, without using the touch screen. The System provides audio and vibratory feedback to the user to confirm the delivery. In the case of an incomplete sequence, the bolus is canceled.
The t:slim X2 insulin pump with interoperable technology system also includes: the Tandem t:slim mobile application and a 3mL (300 insulin unit) t:slim X2 cartridge and a compatible FDA cleared infusion set. The Tandem t:slim mobile application ("mobile app") enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The Tandem t:slim mobile application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem t:slim mobile application will be made available via the Apple® App Store for iOS compatible smartphones and the Android Play Store for Android compatible smartphones based on completed device verification and validation. The t:slim X2 cartridge is a disposable insulin cartridge compatible only with the t:slim X2 pump.
The t:slim X2 pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.
The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.
Based on the provided document, here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence and testing) | Reported Device Performance |
|---|---|---|
| Insulin Compatibility | The device must demonstrate safe and effective compatibility with Lyumjev U-100 Insulin. | "The testing demonstrated that Lyumjev is a compatible insulin with t:slim X2 insulin pump with interoperable technology." |
| Leachable Testing | Leachable levels must be within acceptable safety limits when used with Lyumjev U-100 Insulin. | "The outcome of the insulin compatibility and leachable testing demonstrates that the Subject Device is as safe and as effective as the Predicate Device." |
| Usability/Human Factors | No new usability/human factors issues introduced by the change (Lyumjev compatibility). | "No new Usability/Human Factors testing was performed to support this 510(k) Notification." (Implies satisfactory existing usability and no new risks from the change). |
| Software Verification & Validation | No new software issues introduced by the change (Lyumjev compatibility). | "No new software testing was performed to support this 510(k) Notification." (Implies satisfactory existing software and no new risks from the change). |
| Special Controls | Continued adherence to the Special Controls established for the predicate device. | "Evaluation and adherence to the Special Controls of the Predicate Device (K232380) demonstrates continued assurance of the safety and effectiveness of the Subject Device." |
| Overall Equivalence | The Subject Device (with Lyumjev compatibility) is as safe and effective as the Predicate Device. | "The required technical documentation provided in this 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "insulin compatibility and leachable testing." It only mentions that the testing was performed.
Data provenance is not specified (e.g., country of origin). The testing described appears to be retrospective in the sense that it's focusing on confirming compatibility of a new insulin with an existing device, rather than a de novo clinical trial with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described (insulin compatibility and leachables) would typically involve laboratory analysis and chemical/material science experts, rather than medical experts establishing ground truth in a clinical sense.
4. Adjudication Method for the Test Set
This information is not provided in the document. For the type of testing described (insulin compatibility, leachables), an adjudication method in the context of expert review for ground truth is not typically applicable. Results would be determined by scientific measurement against predefined physicochemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned or performed. This device is an insulin pump; the study is focused on insulin compatibility, not diagnostic imaging or AI-assisted interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned. The device is a physical insulin pump, and the study concerned its compatibility with a new insulin type. While it has "interoperable technology" and a "mobile application," the submitted 510(k) is specifically for the compatibility with Lyumjev U-100 Insulin, not the performance of any new AI algorithms.
7. The Type of Ground Truth Used
For the insulin compatibility and leachable testing, the ground truth would be established by:
- Physicochemical Standards: Referring to established limits for leached substances, and objective measurements of insulin stability, potency, and any physical changes when in contact with the device materials.
- Comparison to Predicate: Demonstrating that the subject device's performance with Lyumjev insulin is equivalent to or better than the predicate device's performance with its approved insulins, according to predefined scientific criteria.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This premarket notification is not for an AI/ML device that requires a training set in the typical sense. It's for an update to an existing medical device to allow compatibility with a new insulin type.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm within the context of this 510(k) summary.
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